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As of Nov 15, 2026, NDA 21794 (Aczone), held by Almirall, was first approved by FDA on Jul 7, 2005, with 8 approved supplements and 0 published complete response letters.
First approved: Jul 7, 2005
Review: Standard
Supplements approved: 8
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Dapsone gel, 5%, is indicated for the topical treatment of acne vulgaris.
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
